MAUDE Adverse Event Report: BAUSCH & LOMB GMBH SILICONE COATED I/A HANDPIECE 45 DEGREE STELLARIS; UNIT, PHACOFRAGMENTATION

Model Number 89510ST

Device Problem Material Split, Cut or Torn (4008)

Patient Problem Insufficient Information (4580)

Event Date 09/08/2022

Event Type  malfunction  

Event Description

Handpiece was used by md in the eye for a portion of the case, then removed while lens was implanted.Upon readying to re-insert for the viscoat removal portion, it was noted that the fluid was squirting out from 3 directions (they start the flow of fluid before entering the eye), instead of the normal 2 directions.Surgeons assessed the handpiece and found that the silicone sheath around the metal head was torn.The surg tech was certain the handpiece wasn't near anything sharp/hard, as it was resting flat on het mayo stand.The handpiece was removed from the field (never re-entered the eye) and replaced with a new handpiece.The case was finished without incident.This had happened a few weeks prior cases (where she had been using the handpiece).

• Brand Name: SILICONE COATED I/A HANDPIECE 45 DEGREE STELLARIS
• Type of Device: UNIT, PHACOFRAGMENTATION
• Manufacturer (Section D): BAUSCH & LOMB GMBH; 400 somerset corporate blvd; bridgewater NJ 08807
• MDR Report Key: 15592641
• MDR Text Key: 301645245
• Report Number: 15592641
• Device Sequence Number: 1
• Product Code: HQC
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/12/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 89510ST
• Device Catalogue Number: 89510ST
• Device Lot Number: FS22029176
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/26/2022
• Event Location: Hospital
• Date Report to Manufacturer: 10/12/2022
• Type of Device Usage: Unknown
• Patient Sequence Number: 1